Efficacy of drug-eluting stents fails to top bare metal in RCT

ESC Congress News 2016 - Rome, Italy

31 Aug 2016

‘Patients treated with DES do not live longer’

Topic(s):

Cardiovascular Surgery

Interventional Cardiology and Cardiovascular Surgery

The largest stent trial ever has found no significant differences in death from any cause or non-fatal MI in patients receiving drug-eluting stents (DES) and bare-metal stents (BMS). The investigator-initiated NORSTENT study, reported in a Hot Line session yesterday, was published simultaneously in the New England Journal of Medicine.

‘Patients treated with DES do not live longer and they do not live better than patients treated with BMS,’ said study presenter Kaare Bonaa from the University of Tromso, Norway. Both contemporary DES and BMS, he added, may be similarly recommended for coronary revascularisation.

‘Although ESC guidelines recommend new DES over BMS as default for coronary revascularisation, this recommendation,’ he said, ‘may need to be modified in light of the NORSTENT findings.’

Aware that findings for bare-metal stents have improved with new stent designs, different metal composition and thinner struts, the NORSTENT investigators felt a re-examination against second-generation DES was needed. The study took place in all eight centres in Norway performing PCI.

Between September 2008 and February 2011, the Norwegian Coronary Stent Trial (NORSTENT), funded by the Norwegian Research Council, randomised 9013 patients with stable or unstable CAD to PCI with either contemporary drug-eluting stents (n=4504) or bare-metal stents (n=4509). In the DES group 96% received everolimus or zotarolimus-eluting stents.

Results at six years showed that the rates of the primary outcome (a composite of death from any cause and non-fatal spontaneous MI) were 16.6% in the DES group and 17.1% in the BMS group. Additionally no differences were found between the two groups for all-cause mortality.

However, the six-year rates of any repeat revascularisation were 16.5% in the DES group and 19.8% in the BMS group (HR 0.76, 95% CI 0.69 to 0.85; P<0.001).

Results from the Seattle Angina Questionnaire show that no differences were found between DES and BMS groups for physical limitation, angina frequency and quality of life.

Bonaa disclosed that on the basis of these results 30 patients would need to be treated with DES to prevent just one repeat revascularisation.

‘As expected, the need for repeat revascularisation was lowered by DES, but this effect was less than anticipated,’ said Bonaa, adding that in some studies it was found to be around half this level.

An accompanying Lancet editorial described the observations as ‘important because they balance the claim by some observers that there is no longer a role for bare-metal stents in PCI because of the superiority of their drug-eluting counterparts in these outcomes’. The editorial added that the trial results ‘should increase confidence’ in choosing bare-metal stents if clinical indications favour that decision and support guideline recommendations endorsing it.